510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130819Substantially Equivalent

Cll- V1 Light Source

Olympus Winter & Ibe GmbH, Center Valley PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130819 is the FDA 510(k) clearance record for CLL- V1 LIGHT SOURCE, a class II device, cleared for Olympus Winter & Ibe GmbH on under FDA product code NTN (Led Light Source). FDA's definition for product code NTN reads: "Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals". FDA records list 43 510(k) clearances for Olympus Winter & Ibe GmbH, from to . As of , FDA records show no recalls naming K130819.

Clearance record

Decision date
Received
(86 days to decision)
Product code
NTN Led Light Source
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Winter & Ibe GmbH 3500 Corporate Pkway, Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTN

Trailing 12 months

FDA records hold no clearances under product code NTN in the trailing twelve months.

FDA records show no clearances under product code NTN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260